HOUSTON, Oct. 25, 2019 /PRNewswire/ -- Soliton, Inc.,
(Nasdaq: SOLY) ("Soliton" or the "Company"), a medical device
company with a novel and proprietary platform technology licensed
from The University of Texas on behalf
of the MD Anderson Cancer Center ("MD Anderson"), today released
interim clinical trial results presented at the American Society
for Dermatologic Surgery ("ASDS") Annual Meeting on October 24, 2019.
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During our keloid and hypertrophic scar (also known as "fibrotic
scars") proof-of-concept trial, we treated 10 people, each of whom
received just a single 6-minute treatment with our Rapid Acoustic
Pulse ("RAP") device. Before treatment, we photographed each
scar with a 3D imaging device that allows for precise measurement
of both the volume and height of the raised scar. 6 weeks
after that single treatment we took another set of 3D images, which
then allowed for an objective comparison of before and after
data.
The graph below provides a recap of the average for nine scars
as one patient was not able to come in for this 6-week
timepoint. There was an average reduction in volume of over
27%, and a reduction in height of almost 17% for the nine
patients.
Importantly, there were no treatment-related adverse events of
any kind and patients reported little pain from the treatment, so
with the primary endpoint of this study being to establish safety
and tolerability of RAP for this indication, we believe we are on
our way to meeting that endpoint.
"We are very pleased with the interim results from this study,"
stated Christopher Capelli, MD,
founder, President and CEO of Soliton. "We will be conducting an
analysis of the 12-week follow-up visit results and providing that
data in the coming months. We view this proof-of-concept
trial as the starting point for demonstrating that our technology
could impact other fibrotic disorders. The same mechanism of
action at work to reduce keloid and hypertrophic scars may extend
to such indications as capsular contraction, Peyronie's Disease,
and even liver fibrosis."
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To learn more about the results of our study, please join our
5:30 p.m. ET webcast covering the
results of our keloid trial in greater detail by registering at
https://www.soliton.com/conference-call-registration/.
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Fibrotic scars, such as keloid and hypertrophic scars, represent
wound healing gone awry. Existing published research suggests
that factors relating to the wound-healing environment (including
stiffness in the extracellular matrix and tension at the boundary
of the scar) can cause fibroblasts to become stuck in a
hyper-productive loop, unable to stop the production of collagen
that leads to the thickened, raised and dense structures often
associated with these fibrotic scars.
The American Osteopathic College of Dermatology estimates that
keloids affect around 10 percent of people,
whereas hypertrophic scars are more common. Keloid
scars are more prevalent among populations with darker skin
pigmentation. Hypertrophic scars affect men and women
from any racial group equally, with people between the ages of
10 and 30 years old being the most likely to be affected.
Grand View Research estimates the global market for keloid and
hypertrophic scars may reach $10.2
billion by 2025. There are few treatment options
available for fibrotic scars, which in addition to being
disfiguring, can also cause significant discomfort.
Currently, the most common treatment is the direct injection of
steroids into the scar, however this can require multiple
injections and may not be a permanent solution.
About Soliton, Inc.
Soliton, Inc. is a medical device company with a novel and
proprietary platform technology licensed from MD Anderson. The
Company's first FDA cleared commercial product will use rapid
pulses of acoustic shockwaves as an accessory to lasers for the
removal of unwanted tattoos. The Company is based in Houston, Texas, and is actively engaged in
bringing the Rapid Acoustic Pulse ("RAP") device to the market. The
Company believes this "Soliton" method has the potential to lower
tattoo removal costs for patients, while increasing profitability
to practitioners, compared to current laser removal methods.
Soliton is investigating potential additional capabilities of the
RAP technology in preclinical testing, including the potential to
assist existing fat reduction technology in the reduction of fat as
well as improving the appearance of cellulite by creating
mechanical stress at the cellular level and inducing significant
collagen growth.
For more information about the Company, please
visit: http://www.soliton.com
Forward-Looking Statements
Some of the statements in this release are forward-looking
statements within the meaning of Section 27A of the Securities Act
of 1933, Section 21E of the Securities Exchange Act of 1934 and the
Private Securities Litigation Reform Act of 1995, which involve
risks and uncertainties. Forward-looking statements in this press
release include, without limitation, the ability of the Soliton RAP
device to demonstrate safety and efficacy in the reduction of
keloid and hypertrophic scars, the ability for Soliton to receive
FDA clearance for these additional indications and the ability of
Soliton to pursue treatment of other fibrotic disorders. These
statements relate to future events, future expectations, plans and
prospects. Although Soliton believes that the expectations
reflected in such forward-looking statements are reasonable as of
the date made, expectations may prove to have been materially
different from the results expressed or implied by such
forward-looking statements. Soliton has attempted to identify
forward-looking statements by terminology including ''believes,''
''estimates,'' ''anticipates,'' ''expects,'' ''plans,''
''projects,'' ''intends,'' ''potential,'' ''may,'' ''could,''
''might,'' ''will,'' ''should,'' ''approximately'' or other words
that convey uncertainty of future events or outcomes to identify
these forward-looking statements. These statements are only
predictions and involve known and unknown risks, uncertainties, and
other factors, including those discussed under in our SEC filings,
including under the heading "Item 1A. Risk Factors" in the Form
10-K for year ended December 31, 2018
we filed with the SEC and updated from time to time in our Form
10-Q filings and in our other public filings with the SEC. Any
forward-looking statements contained in this release speak only as
of its date. Soliton undertakes no obligation to update any
forward-looking statements contained in this release to reflect
events or circumstances occurring after its date or to reflect the
occurrence of unanticipated events.
Additional Information
Clinical Trial Results Graph
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